SQA

FEBRUARY 15, 2023

In addition to these classic topics, developments in the field of artificial intelligence (AI) will be included in the future. There are currently no regulatory guidelines or expectations for AI or machine learning (ML). .” References to ICH Q9 and thus to quality risk management will also be added.

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Health Law Advisor

JUNE 1, 2023

Would it surprise you if I told you that a popular and well-respected machine learning algorithm developed to predict the onset of sepsis has shown some evidence of racial bias? [1] 11] Healthcare lawyers, on the other hand, must start by figuring out who the categories of people are that need to be statistically evaluated.

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Health Populi

JANUARY 2, 2020

Forbes ran a column on CES 2020 discussing AI in hearing and vision. Hearables have been emerging at CES for a few years, and now vision will be a newer category to watch. (As Subsequently, ResMed joined with Dr. Oz to launch SleepScore Labs – an exhibitor at CES 2020 in the fast-growing sleep category at the Show.

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SQA

MAY 24, 2023

The ICH M7(R2) Addendum describes Acceptable Intakes (AIs) or Permissible Daily Exposures (PDEs) which have been derived for a set of chemicals that are considered to be mutagens and carcinogens and are common in pharmaceutical manufacturing or are useful to illustrate the principles for deriving compound-specific intakes described in ICH M7(R2).

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Health Law Advisor

AUGUST 10, 2023

Introduction Hardly a day goes by when we don’t see some media report of health care providers experimenting with machine learning, and more recently with generative AI, in the context of patient care. But the question is, to what extent do health care providers need to worry about FDA requirements as they use AI?

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SQA

OCTOBER 18, 2022

ISO/IEC 23053:2022: Framework for Artificial Intelligence (AI) Systems Using Machine Learning (ML), June 2022. ISO/IEC 23053:2022 establishes an Artificial Intelligence (AI) and Machine Learning (ML) framework for describing a generic AI system using ML technology.

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Jane Sarashon

DECEMBER 13, 2021

This year-end/New Year 2022 post on my Health Populi blog will weave together many of the key findings from these consumer health/care reports that are most resonating with me and the work I’m doing…. machine learning, AI) and should be mindful about data privacy and ownership vis-à-vis transparency and patient control of personal data.

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